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Clinical Trials/NCT07125651
NCT07125651Not yet recruitingNot Applicable

Prevalence of Gastrointestinal Bleeding in Ischemic Heart Disease Patients Undergoing Single Compared to Dual Antiplatelet Treatment

Assiut University0 sites112 target enrollmentStarted: September 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
112
Primary Endpoint
Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatment

Study Overview

Brief Summary

Gastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy. This study aims to compare the prevalence and risk of gastrointestinal bleeding in ischemic heart disease patients on single versus dual antiplatelet therapy, and to explore strategies for reducing gastrointestinal bleeding in these patients, enhancing treatment safety without compromising cardiovascular protection.

Detailed Description

Gastrointestinal (GI) bleeding refers to blood loss within the gastrointestinal tract, including the esophagus, stomach, small and large intestines, rectum, and anus. It is classified as upper GI bleeding-originating proximal to the ligament of Treitz (esophagus, stomach, first and second parts of the duodenum)-and lower GI bleeding, which originates distal to this ligament (remaining duodenum, jejunum, ileum, colon, rectum, and anus). GI bleeding may be acute, with sudden and severe blood loss, or chronic, involving slow, recurrent bleeding that is less obvious but still clinically significant.

Ischemic heart disease (IHD) is caused by reduced blood flow to the heart muscle due to narrowing or blockage of the coronary arteries, mainly from atherosclerosis. This can result in chest pain, heart attacks, and other cardiovascular complications.

Antiplatelet drugs, such as aspirin and clopidogrel, inhibit platelet aggregation to prevent blood clots and are essential in IHD management. Single antiplatelet therapy (SAPT) uses one agent, while dual antiplatelet therapy (DAPT) combines two agents for stronger protection against thrombotic events.

Both SAPT and DAPT improve cardiovascular outcomes in IHD patients, with SAPT commonly used for long-term prevention and DAPT recommended after acute coronary events or interventions.

Antiplatelet drugs, like aspirin and clopidogrel, increase GI bleeding risk by inhibiting platelet aggregation, impairing clot formation, and, in the case of aspirin, directly irritating the stomach lining, making it easier for ulcers or erosions to bleed. The risk is higher with dual therapy.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients (aged 18 years old and older) who were diagnosed ischemic heart disease on single or dual antiplatelet therapy and developed gastrointestinal bleeding (manifestation of hematemesis, melena or bleeding per rectum).

Exclusion Criteria

  • Patients on anticoagulant.
  • Patients with bleeding tendencies.
  • Individuals with other comorbidities.
  • patients with acute coronary syndrome.
  • Uncooperative patients.

Outcomes

Primary Outcomes

Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatment

Time Frame: Baseline

Gastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdulrahman Antar Mohamed

Dr

Assiut University

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